Mattress Sheet for Neo Cot(5 pcs/pkg) - ATOM MEDICAL CORPORATION

Duns Number:690632047

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

26122

Brand Name

Mattress Sheet for Neo Cot(5 pcs/pkg)

Version/Model Number

26122

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

FMW

Product Code Name

Cover, Mattress (Medical Purposes)

Device Record Status

Public Device Record Key

1d5651ef-8dea-4637-bc43-72dbd11ed396

Public Version Date

June 19, 2020

Public Version Number

4

DI Record Publish Date

October 28, 2016

Additional Identifiers

Package DI Number

14942962261224

Quantity per Package

1

Contains DI Package

04942962261227

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box

"ATOM MEDICAL CORPORATION" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 4
2 A medical device with a moderate to high risk that requires special controls. 40